AXS-05

Treatment Resistant Depression (TRD)

What is Treatment Resistant Depression?

Patients diagnosed with MDD (Major Depressive Disorder) are defined as having TRD if they have failed two or more antidepressant therapies.

MDD is a serious condition characterized by depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and which impairs social, occupational, educational, or other important functioning.

MDD is highly prevalent and difficult to treat. According to the National Institute of Health, or NIH, an estimated 6.7% of U.S. adults experience MDD each year, while 3.3% of individuals 13 to 18 years of age experience a seriously debilitating depressive disorder. Results of the Sequenced Treatment Alternatives to Relieve Depression, or STAR*D trial, funded by the National Institute of Mental Health, indicate that nearly two thirds of diagnosed and treated patients do not experience adequate treatment response with first line therapy, and that the majority of these initial failures also fail second line treatment.

Key Opinion Leader Presentations

AXS-05

AXS-05 is a novel, oral, investigational drug product under development for the treatment of central nervous system (CNS) disorders. AXS-05 utilizes Axsome’s technology of combining bupropion and dextromethorphan. Dextromethorphan is an NMDA receptor antagonist, sigma-1 receptor agonist, and inhibitor of the serotonin and norepinephrine transporters. Bupropion serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is an investigational drug product not approved by the FDA.

TRD CLINICAL TRIAL

STRIDE-1 Study

AXS-05 is being evaluated in the STRIDE-1 (Symptom Treatment in Resistant Depression 1) study. STRIDE-1 is a Phase 3 multicenter, randomized, double-blind, active-controlled trial to assess the efficacy and safety of AXS-05 in the treatment of TRD. Patients with MDD who have previously failed one or two antidepressant treatments will be treated in an open-label fashion with bupropion during a 6-week lead-in period. Patients who fail to respond to bupropion during this lead-in period will be randomly assigned in a 1:1 ratio to treatment with bupropion or AXS-05 in a double-blind fashion. The primary endpoint is the change in the Montgomery Asberg Depression Rating Scale. We anticipate that approximately 346 subjects will be randomized in the trial.